This position acts as a point of contact with regulatory authorities for questions and issues regarding specific applications. In this role, you will work with significant levels of autonomy in the coordination and execution in the assembly and approval of drug applications to regulatory authorities, including the collection and collation of data/information, and writing needed to complete an application.

• Assemble Investigational New Drug (IND) and New Drug Applications (NDA) and other regulatory applications for drugs - develop new or amend existing applications: work collectively with multidisciplinary teams for assimilation of relevant information, author the application, assist junior level associates on assembling components of the application, and review application for accuracy and completeness following regulatory guidelines.
• Anticipate regulatory consequences - develop and maintain knowledge of the history, manufacture, and materials of assigned products and product lines in order to assess (A) the consequences of regulatory changes for the product and (B) the regulatory consequences of changes in the manufacture, materials, or marketing of the product.
• Maintain high level of knowledge of regulations, the regulatory process, and the application of regulations to assigned products - expand regulatory background through work on projects, researching available documents and attending relevant training. Anticipate how future developments in the regulations and standards governing regulatory submissions may affect company policy and applications.
• Represent Regulatory on Core Teams in the Product Development Process. Develop regulatory strategy for projects in various stages of development. Defend regulatory position both internally and externally. Negotiate agreement to novel approaches to problem solving. Liaison with other regulatory functions and clinical team to provide cohesive strategy and timelines for product development process.
• Liaison with FDA and contacts outside of company. Determine specific needs and organize the assembly of an appropriate response. Effectively communicate issues from FDA to other department personnel and company issues to FDA.
• Prepare submissions in an electronic document management system. Requires advanced computer skills, working knowledge of eCTD, organizational planning and ability to multi-task.
• Process, interpret and provide recommendations for complex, unusual issues.
• Critically review documentation for regulatory submissions and provide input for necessary revisions.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor Degree in Chemistry, Pharmacy, Biology, Life Science or equivalent preferred.
• 3 or more years of relevant work experience in pharmaceutical Regulatory Affairs is required.
• Previous FDA (ANDA, NDA's, Drug Master Files) submissions experience is required.
• Must have knowledge of CMC documentation.
• Self-starter who takes initiative to learn, grow and excel as a Regulatory Affairs professional.
• Knowledge of Windows based software programs such as Word and Excel.
• Understands regulatory application processes and the basis of regulations.
• Background in the chemical and life sciences sufficient to interpret data/information, review the work of others for technical adequacy, draft an application, and interact with reviewers at the Agency.
• Familiarity with pharmaceutical manufacturing equipment and technology is of value for this position.
• Fundamental knowledge of federal acts and regulations affecting proposed and marketed products.
• Excellent oral and written communication skills.
• Strong interpersonal skills, including ability to remain calm, professional, diplomatic and positive.

Working Conditions:

• This position will work in typical office conditions with extensive time using personal computer equipment.
• May be required to sit or stand for long periods of time while performing duties.
• Close attention to detail required.
• Willingness to work in a team-based environment.
• The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.